Trial Outcomes & Findings for A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations (NCT NCT01970865)
NCT ID: NCT01970865
Last Updated: 2024-08-12
Results Overview
DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \>7 days; febrile neutropenia; grade\>=3 neutropenic infection; grade\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\>=3 pancreatitis; grade\>=3 toxicities (excluding grade \>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \>=3 QT interval corrected for heart rate (QTc) prolongation, or asymptomatic grade \>=3 prolongation that had been confirmed by repeat testing, re-evaluation by qualified person, persisted after correction of reversible causes; \>=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of 21 prescribed daily total dose due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicity attributable to study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
364 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2024-08-12
Participant Flow
A total of 364 participants were enrolled in this study.
Participant milestones
| Measure |
10 mg QD (Phase 1)
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
Japan Lead-In Cohort (LIC)
Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
|
Drug-drug Interaction (DDI) Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
12
|
17
|
3
|
3
|
3
|
3
|
4
|
30
|
27
|
60
|
65
|
46
|
47
|
3
|
32
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
1
|
2
|
18
|
7
|
18
|
8
|
3
|
7
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
10
|
14
|
3
|
3
|
3
|
2
|
2
|
12
|
20
|
42
|
57
|
43
|
40
|
1
|
26
|
Reasons for withdrawal
| Measure |
10 mg QD (Phase 1)
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
Japan Lead-In Cohort (LIC)
Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
|
Drug-drug Interaction (DDI) Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
3
|
6
|
9
|
3
|
2
|
3
|
2
|
2
|
8
|
13
|
25
|
46
|
37
|
22
|
1
|
17
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
4
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
2
|
3
|
8
|
3
|
2
|
3
|
0
|
2
|
|
Overall Study
Participant refused further follow-up
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
7
|
8
|
3
|
11
|
0
|
6
|
Baseline Characteristics
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
Baseline characteristics by cohort
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
25 mg QD (Phase 1)
n=3 Participants
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=12 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=17 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
150 mg QD (Phase 1)
n=3 Participants
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
200 mg QD (Phase 1)
n=3 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=46 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
Japan Lead-In Cohort (LIC)
n=3 Participants
Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
|
Drug-drug Interaction (DDI) Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
Total
n=364 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Customized
18-44 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
91 Participants
n=667 Participants
|
|
Age, Customized
45-64 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
34 Participants
n=36 Participants
|
37 Participants
n=36 Participants
|
26 Participants
n=24 Participants
|
27 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
20 Participants
n=44 Participants
|
204 Participants
n=667 Participants
|
|
Age, Customized
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
69 Participants
n=667 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
38 Participants
n=36 Participants
|
37 Participants
n=36 Participants
|
25 Participants
n=24 Participants
|
27 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
15 Participants
n=44 Participants
|
206 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
28 Participants
n=36 Participants
|
21 Participants
n=24 Participants
|
20 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
17 Participants
n=44 Participants
|
158 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
32 Participants
n=36 Participants
|
27 Participants
n=24 Participants
|
25 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
21 Participants
n=44 Participants
|
190 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
BLACK
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
23 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
16 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
11 Participants
n=44 Participants
|
124 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Others
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
13 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
31 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD. Here, "Overall Number Analyzed" signifies participants analyzed for this outcome measure.
DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \>7 days; febrile neutropenia; grade\>=3 neutropenic infection; grade\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\>=3 pancreatitis; grade\>=3 toxicities (excluding grade \>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \>=3 QT interval corrected for heart rate (QTc) prolongation, or asymptomatic grade \>=3 prolongation that had been confirmed by repeat testing, re-evaluation by qualified person, persisted after correction of reversible causes; \>=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of 21 prescribed daily total dose due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicity attributable to study drug.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=11 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=2 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
With DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
No DLT
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
Data missing
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with central nervous system (CNS) metastases in the ITT analysis set were used for intracranial response assessment. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 milliliter (mm) on Target Lesions electronic case report form (eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 percent (%) or more decrease in sum of lesion dimensions (SLD) of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=60 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=65 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall and Intracranial Objective Response (Phase 2)
Objective response
|
90.0 Percentage of participants
Interval 73.5 to 97.9
|
74.1 Percentage of participants
Interval 53.7 to 88.9
|
50.8 Percentage of participants
Interval 37.5 to 64.1
|
41.5 Percentage of participants
Interval 29.4 to 54.4
|
34.8 Percentage of participants
Interval 21.4 to 50.2
|
—
|
—
|
36.2 Percentage of participants
Interval 22.7 to 51.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Overall and Intracranial Objective Response (Phase 2)
Intracranial objective response
|
75.0 Percentage of participants
Interval 34.9 to 96.8
|
58.8 Percentage of participants
Interval 32.9 to 81.6
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
55.6 Percentage of participants
Interval 40.0 to 70.4
|
39.5 Percentage of participants
Interval 24.0 to 56.6
|
—
|
—
|
56.0 Percentage of participants
Interval 34.9 to 75.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until CR or PR (maximum of 8 years approximately)Population: The ITT analysis set was used for overall response assessment and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
Objective response (OR) refers to confirmed CR or PR according to RECIST version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=41 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=12 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)
Objective response
|
39.0 Percentage of participants
Interval 24.2 to 55.5
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)
Intracranial objective response
|
41.2 Percentage of participants
Interval 24.6 to 59.3
|
50.0 Percentage of participants
Interval 15.7 to 84.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment to the first documentation of objective tumor response (CR or PR) (maximum of 8 years approximately)Population: TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.
Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=16 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=6 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)
TTR
|
1.4 Months
Interval 1.2 to 15.2
|
1.4 Months
Interval 1.2 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)
Intracranial TTR
|
1.4 Months
Interval 1.2 to 20.1
|
1.4 Months
Interval 1.1 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately)Population: DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data foe every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=16 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=6 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 21 Months to <24 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 9 Months to <12 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 18 Months to <21 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · <3 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 3 Months to <6 Months
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 6 Months to <9 Months
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 9 Months to <12 Months
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 12 Months to <15 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 15 Months to <18 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · 18 Months to <21 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with DOR · >=24 Months
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · <3 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 3 Months to <6 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 6 Months to <9 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 12 Months to <15 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 15 Months to <18 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · 21 Months to <24 Months
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored-DOR · >=24 Months
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · <3 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 3 Months to <6 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 6 Months to <9 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 9 Months to <12 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 12 Months to <15 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 15 Months to <18 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 18 Months to <21 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · 21 Months to <24 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants with intracranial DOR · >=24 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · <3 Months
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 3 Months to <6 Months
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 6 Months to <9 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 9 Months to <12 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 12 Months to <15 Months
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 15 Months to <18 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 18 Months to <21 Months
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · 21 Months to <24 Months
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
Participants censored- intracranial DOR · >=24 Months
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.
Tumor response was evaluated according to RECIST version 1.1, and disease control: confirmed CR, confirmed PR, or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. CR was defined as disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as 30% or more decrease in SLD of target lesions, taking as reference baseline SLD. Progressive disease: 20% or more increase in SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition to relative increase of 20%, SLD must also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=41 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=12 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
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75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
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200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
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75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1)
DCR at Week 12
|
53.7 Percentage of participants
Interval 37.4 to 69.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
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Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1)
DCR at Week 24
|
39.0 Percentage of participants
Interval 24.2 to 55.5
|
50.0 Percentage of participants
Interval 21.1 to 78.9
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Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1)
Intracranial DCR at Week 12
|
50.0 Percentage of participants
Interval 32.4 to 67.6
|
37.5 Percentage of participants
Interval 8.5 to 75.5
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Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1)
Intracranial DCR at Week 24
|
41.2 Percentage of participants
Interval 24.6 to 59.3
|
37.5 Percentage of participants
Interval 8.5 to 75.5
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SECONDARY outcome
Timeframe: 3 yearsPopulation: The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
The probability of the first event being a CNS progression, a non-CNS progression, or death was evaluated with a competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to the analysis set. The time to first event being a Competing Event (either "CNS progression" or "non CNS progression" or "Death") was defined as time from first dose until the date of that specific event. Participants not known to have any of the Competing Events were censored on the date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as a competing cause of failure for the analysis of other type of events. For each type of event, the cumulative incidence function corresponding to the nearest time point preceding 1 year is presented. The results are based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=53 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1)
CNS progression
|
0.260 Probability of events
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Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1)
Non CNS progression
|
0.352 Probability of events
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Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1)
Death
|
0.060 Probability of events
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SECONDARY outcome
Timeframe: From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately)Population: PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
PFS was defined as the time from the first dose of study treatment to the first documentation of objective PD or to death on study due to any cause, whichever came first. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=41 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=12 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) (Phase 1)
|
5.4 Months
Interval 2.7 to 11.8
|
10.1 Months
Interval 1.6 to 33.0
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SECONDARY outcome
Timeframe: 3 yearsPopulation: The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=41 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=12 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) (Phase 1)
|
22.3 Months
Interval 11.4 to
A large proportion of participants in the analysis set had their OS data censored, and number of participants dead by the cutoff date of this report was small, so it's impossible to derive such summary statistics.
|
NA Months
Interval 4.7 to
A large proportion of participants in the analysis set had their OS data censored, and number of participants dead by the cutoff date of this report was small, so it's impossible to derive such summary statistics.
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—
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1)
|
50.80 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
149.2 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 71
|
NA Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 390 and 423 ng/mL, respectively.
|
489.1 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
595.5 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
1201 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
202.2 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
760.0 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
594.9 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
507.2 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Maximum Observed Plasma Concentration (Cmax) of PF-06463922 was observed directly from data.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)
|
67.29 ng/mL
Geometric Coefficient of Variation 18
|
138.1 ng/mL
Geometric Coefficient of Variation 35
|
359.7 ng/mL
Geometric Coefficient of Variation 27
|
429.6 ng/mL
Geometric Coefficient of Variation 48
|
550.2 ng/mL
Geometric Coefficient of Variation 32
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 760 and 1430 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 370 ng/mL.
|
541.0 ng/mL
Geometric Coefficient of Variation 42
|
550.0 ng/mL
Geometric Coefficient of Variation 23
|
600.5 ng/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Tmax of PF-06463922 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1)
|
1.98 Hours
Interval 1.0 to 2.97
|
2.00 Hours
Interval 0.5 to 2.05
|
1.25 Hours
Interval 0.5 to 2.0
|
1.09 Hours
Interval 0.5 to 4.03
|
1.96 Hours
Interval 0.517 to 4.33
|
2.00 Hours
Interval 1.18 to 3.0
|
1.20 Hours
Interval 0.5 to 1.97
|
1.05 Hours
Interval 1.0 to 3.0
|
1.23 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.1 to 3.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Tmax of PF-06463922 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)
|
1.00 Hours
Interval 1.0 to 1.08
|
1.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.92 to 2.75
|
1.03 Hours
Interval 0.5 to 2.0
|
1.13 Hours
Interval 1.0 to 4.0
|
1.61 Hours
Interval 1.22 to 2.0
|
0.50 Hours
Interval 0.5 to 0.5
|
1.30 Hours
Interval 1.0 to 24.0
|
0.55 Hours
Interval 0.5 to 2.05
|
2.00 Hours
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, and 24 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Single Oral Doses (Phase 1)
|
488.2 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 21
|
1387 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
NA Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 3310 and 3880 ng\*hr/mL, respectively.
|
3990 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
5110 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
11410 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
982.4 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 9
|
7474 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 73
|
2996 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
2925 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=1 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1)
|
752.1 ng*hr/mL
Geometric Coefficient of Variation 26
|
1701 ng*hr/mL
Geometric Coefficient of Variation 29
|
3367 ng*hr/mL
Geometric Coefficient of Variation 39
|
4107 ng*hr/mL
Geometric Coefficient of Variation 53
|
5121 ng*hr/mL
Geometric Coefficient of Variation 30
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 4480 and 12900 ng\*hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 2140 ng\*hr/mL.
|
6157 ng*hr/mL
Geometric Coefficient of Variation 9
|
3574 ng*hr/mL
Geometric Coefficient of Variation 35
|
4058 ng*hr/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=1 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=2 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=11 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=15 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=3 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=1 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=2 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 Following Single Oral Doses (Phase 1)
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 698 ng\*hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 7210 and 7240 ng\*hr/mL, respectively.
|
7663 ng*hr/mL
Geometric Coefficient of Variation 79
|
8236 ng*hr/mL
Geometric Coefficient of Variation 25
|
18340 ng*hr/mL
Geometric Coefficient of Variation 61
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 6860 ng\*hr/mL.
|
6318 ng*hr/mL
Geometric Coefficient of Variation 56
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 2630 and 3690 ng\*hr/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=1 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=2 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=11 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=15 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=3 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=1 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=2 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-06463922 Following Single Oral Doses (Phase 1)
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 14.3 L/hr.
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 6.91 and 6.94 L/hr, respectively.
|
9.788 Liter/hour (L/hr)
Geometric Coefficient of Variation 79
|
12.14 Liter/hour (L/hr)
Geometric Coefficient of Variation 25
|
10.90 Liter/hour (L/hr)
Geometric Coefficient of Variation 61
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 10.9 L/hr.
|
15.83 Liter/hour (L/hr)
Geometric Coefficient of Variation 56
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 9.48 and 13.3 L/hr, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=1 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-06463922 Following Multiple Oral Doses (Phase 1)
|
13.27 L/hr
Geometric Coefficient of Variation 26
|
14.72 L/hr
Geometric Coefficient of Variation 29
|
14.84 L/hr
Geometric Coefficient of Variation 39
|
17.66 L/hr
Geometric Coefficient of Variation 48
|
19.52 L/hr
Geometric Coefficient of Variation 30
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 15.5 and 44.6 L/hr, respectively.
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 16.3 L/hr.
|
24.37 L/hr
Geometric Coefficient of Variation 9
|
20.99 L/hr
Geometric Coefficient of Variation 35
|
22.37 L/hr
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf\*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=1 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=2 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=11 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=15 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=3 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=1 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=2 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06463922 Following Single Oral Doses (Phase 1)
|
NA Liters (L)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 373 L.
|
NA Liters (L)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 166 and 307 L, respectively.
|
367.9 Liters (L)
Geometric Coefficient of Variation 54
|
356.3 Liters (L)
Geometric Coefficient of Variation 39
|
307.8 Liters (L)
Geometric Coefficient of Variation 41
|
NA Liters (L)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 410 L.
|
378.3 Liters (L)
Geometric Coefficient of Variation 54
|
NA Liters (L)
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 362 and 472 L, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Rac was calculated as Day 15 AUCtau/Day -7 AUCtau or Day 1 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively).
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=15 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=1 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1)
|
1.543 Ratio
Standard Deviation 0.075056
|
1.237 Ratio
Standard Deviation 0.20817
|
1.105 Ratio
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values.
|
1.121 Ratio
Standard Deviation 0.44575
|
1.071 Ratio
Standard Deviation 0.31138
|
0.6500 Ratio
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values.
|
NA Ratio
Standard Deviation NA
These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 2.09.
|
1.000 Ratio
Standard Deviation 0.79137
|
1.231 Ratio
Standard Deviation 0.35228
|
1.523 Ratio
Standard Deviation 0.29569
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=1 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=2 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=11 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=15 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=3 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=1 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=2 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1)
|
NA Hours (hr)
Standard Deviation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 18.0 hr.
|
23.70 Hours (hr)
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 16.6 and 30.8 hr, respectively.
|
27.22 Hours (hr)
Standard Deviation 8.2961
|
20.89 Hours (hr)
Standard Deviation 5.0308
|
19.80 Hours (hr)
Standard Deviation 3.3045
|
NA Hours (hr)
Standard Deviation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 26.0 hr.
|
17.18 Hours (hr)
Standard Deviation 5.1874
|
25.55 Hours (hr)
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 24.6 and 26.5 hr, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=1 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=2 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=11 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=14 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=2 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=1 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=1 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 1)
|
NA Ratio
Standard Deviation NA
These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 0.993.
|
0.5600 Ratio
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 0.401 and 0.719, respectively.
|
0.6131 Ratio
Standard Deviation 0.29021
|
0.6603 Ratio
Standard Deviation 0.18604
|
0.3935 Ratio
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 0.384 and 0.403, respectively.
|
NA Ratio
Standard Deviation NA
These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 0.542.
|
0.7687 Ratio
Standard Deviation 0.13552
|
NA Ratio
Standard Deviation NA
These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 0.815.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. As planned, this parameter was only analyzed for 100 mg QD group. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Renal clearance was calculated as Aetau/AUCtau, where Aetau was the cumulative amount of drug recovered unchanged in urine up to dosing interval tau (24 hours for QD dosing regimen), and AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen).
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) of PF-06463922 (Phase 1)
|
61.31 ml/hour
Geometric Coefficient of Variation 58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. As planned, this parameter was only analyzed for 100 mg QD group. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Dosing interval was 24 hours for QD dosing regimen. Aetau% was calculated as 100\*Ae24/dose, where Ae24 was the cumulative amount of drug recovered unchanged in urine up to 24 hours post-dose.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of PF-06463922 Recovered Unchanged in Urine up to Dosing Interval (AEtau%) (Phase 1)
|
0.4017 Percentage of recovered PF-06463922
Standard Deviation 0.11074
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.
Cmax of midazolam was observed directly from data. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflected the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflected the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Midazolam (Phase 1)
Cycle 1 Day 15
|
9.697 ng/mL
Geometric Coefficient of Variation 40
|
5.734 ng/mL
Geometric Coefficient of Variation 43
|
—
|
—
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—
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—
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—
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—
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—
|
|
Maximum Observed Plasma Concentration (Cmax) of Midazolam (Phase 1)
Day -7
|
16.06 ng/mL
Geometric Coefficient of Variation 42
|
11.56 ng/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.
Tmax of midazolam was observed directly from data as time of first occurrence. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of Midazolam (Phase 1)
Day -7
|
0.50 Hours
Interval 0.5 to 1.0
|
0.50 Hours
Interval 0.5 to 0.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Time for Cmax (Tmax) of Midazolam (Phase 1)
Cycle 1 Day 15
|
0.50 Hours
Interval 0.5 to 1.0
|
0.50 Hours
Interval 0.5 to 0.533
|
—
|
—
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—
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—
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—
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—
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—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of midazolam was determined using linear/log trapezoidal method. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1)
Day -7
|
51.30 ng*hr/mL
Geometric Coefficient of Variation 47
|
36.49 ng*hr/mL
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1)
Cycle 1 Day 15
|
20.43 ng*hr/mL
Geometric Coefficient of Variation 18
|
14.44 ng*hr/mL
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)
Day -7
|
54.53 ng*hr/mL
Geometric Coefficient of Variation 43
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 42.2 and 46.8 ng\*hr/mL, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)
Cycle 1 Day 15
|
21.32 ng*hr/mL
Geometric Coefficient of Variation 18
|
16.09 ng*hr/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available. Here, 'Number Analyzed' signifies participants evaluable for specified rows
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of Midazolam (Phase 1)
Day -7
|
36.68 L/hr
Geometric Coefficient of Variation 43
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 42.7 and 47.4 L/hr, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Oral Clearance (CL/F) of Midazolam (Phase 1)
Cycle 1 Day 15
|
93.86 L/hr
Geometric Coefficient of Variation 18
|
124.2 L/hr
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf\*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1)
Day -7
|
229.0 Liters
Geometric Coefficient of Variation 7
|
NA Liters
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 161 and 486 L, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1)
Cycle 1 Day 15
|
404.4 Liters
Geometric Coefficient of Variation 51
|
702.2 Liters
Geometric Coefficient of Variation 100
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life of Midazolam (Phase 1)
Day -7
|
4.620 Hours
Standard Deviation 1.9328
|
5.120 Hours
Standard Deviation NA
Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 2.35 and 7.89 hr, respectively.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Terminal Half-Life of Midazolam (Phase 1)
Cycle 1 Day 15
|
3.343 Hours
Standard Deviation 2.0358
|
5.257 Hours
Standard Deviation 5.0639
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (up to 28 days)Population: CNA peripheral blood analysis set included all participants of the ITT analysis set who had at least 1 molecular biomarker assayed.
Plasma circulating nucleic acid (CNA) samples were analyzed for ALK kinase domain mutations by digital polymerase chain reaction (PCR) BEAMing technology. Number of participants with one or more ALK mutations is presented.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=40 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 1)
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (up to 28 days)Population: Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).
Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=40 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 1)
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until end of treatment (maximum of 8 years approximately)Population: Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=43 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in role functioning
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in role functioning
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in global QoL
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in global QoL
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in global QoL
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in physical functioning
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in physical functioning
|
29 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in physical functioning
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in role functioning
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in emotional functioning
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in emotional functioning
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in emotional functioning
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in cognitive functioning
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in cognitive functioning
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in cognitive functioning
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in social functioning
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in social functioning
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in social functioning
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in fatigue
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in fatigue
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in fatigue
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in nausea and vomiting
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in nausea and vomiting
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
worsened in nausea and vomiting
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in pain
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in pain
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in pain
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in dyspnea
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in dyspnea
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in dyspnea
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in insomnia
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in insomnia
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in insomnia
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in appetite loss
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in appetite loss
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in appetite loss
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in constipation
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in constipation
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in constipation
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in diarrhea
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in diarrhea
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in diarrhea
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Improved in financial difficulties
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Stable in financial difficulties
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Worsened in financial difficulties
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until end of treatment (maximum of 8 years approximately)Population: PRO evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=43 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in alopecia
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in alopecia
|
29 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in alopecia
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in chest pain
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in dyspnea
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in dyspnea
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in dyspnea
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in coughing
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in coughing
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in coughing
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in hemoptysis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in hemoptysis
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in hemoptysis
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in sore mouth
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in sore mouth
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in sore mouth
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in dysphagia
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in dysphagia
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in dysphagia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in peripheral neuropathy
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in peripheral neuropathy
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in peripheral neuropathy
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in chest pain
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in chest pain
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in arm or shoulder pain
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in arm or shoulder pain
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in arm or shoulder pain
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Improved in pain in other parts
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Stable in pain in other parts
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)
Worsened in pain in other parts
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycle 1-52, and end of treatment (up to 3 years)Population: MMSE assessment evaluable analysis set included all participants in the safety analysis set (all participants who received at least 1 dose of PF-06463922) who completed a baseline and at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specified rows.
In Phase 1, the MMSE was collected to assess mental status. The MMSE is a 30 item questionnaire that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30 and minimum score is 0. Highest score indicates no cognitive impairment, lowest score indicates severe cognitive impairment. The MMSE was removed under Amendment 6 of the study protocol, and not required for Phase 2, as the tool was not considered meaningful for assessment of cognitive function.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=2 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=9 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=16 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=2 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=2 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 33 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
1.3 Units on a scale
Standard Deviation 2.31
|
0.5 Units on a scale
Standard Deviation 0.58
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 31 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
1.0 Units on a scale
Standard Deviation 2.65
|
0.7 Units on a scale
Standard Deviation 0.82
|
3.0 Units on a scale
Standard Deviation 4.24
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 32 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
1.3 Units on a scale
Standard Deviation 2.31
|
0.4 Units on a scale
Standard Deviation 0.55
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 2 Day 1
|
2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.3 Units on a scale
Standard Deviation 0.58
|
2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.3 Units on a scale
Standard Deviation 1.41
|
0.0 Units on a scale
Standard Deviation 1.79
|
4.0 Units on a scale
Standard Deviation 4.24
|
0.0 Units on a scale
Standard Deviation 0.00
|
4.7 Units on a scale
Standard Deviation 8.08
|
0.0 Units on a scale
Standard Deviation 0.00
|
-0.3 Units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 10 Day 1
|
-5.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.5 Units on a scale
Standard Deviation 0.71
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
-0.1 Units on a scale
Standard Deviation 0.88
|
6.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
6.5 Units on a scale
Standard Deviation 9.19
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.7 Units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 19 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.8 Units on a scale
Standard Deviation 1.79
|
-0.6 Units on a scale
Standard Deviation 2.65
|
3.5 Units on a scale
Standard Deviation 4.95
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 28 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
1.0 Units on a scale
Standard Deviation 2.00
|
0.7 Units on a scale
Standard Deviation 0.76
|
3.0 Units on a scale
Standard Deviation 2.83
|
—
|
-2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 36 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 44 Day 1
|
—
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
3.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 30 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.8 Units on a scale
Standard Deviation 1.50
|
0.4 Units on a scale
Standard Deviation 0.55
|
3.0 Units on a scale
Standard Deviation 2.83
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.0 Units on a scale
Standard Deviation 1.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 1 Day 1
|
1.0 Units on a scale
Standard Deviation 1.41
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
-0.9 Units on a scale
Standard Deviation 2.27
|
0.8 Units on a scale
Standard Deviation 1.39
|
—
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 3 Day 1
|
2.0 Units on a scale
Standard Deviation 0.00
|
0.3 Units on a scale
Standard Deviation 0.58
|
-0.5 Units on a scale
Standard Deviation 0.71
|
-0.6 Units on a scale
Standard Deviation 1.85
|
0.2 Units on a scale
Standard Deviation 1.52
|
3.0 Units on a scale
Standard Deviation 2.83
|
—
|
5.0 Units on a scale
Standard Deviation 8.49
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.0 Units on a scale
Standard Deviation 1.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 4 Day 1
|
5.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.5 Units on a scale
Standard Deviation 0.71
|
1.5 Units on a scale
Standard Deviation 2.12
|
-1.1 Units on a scale
Standard Deviation 1.81
|
0.0 Units on a scale
Standard Deviation 1.47
|
-0.5 Units on a scale
Standard Deviation 3.54
|
—
|
2.0 Units on a scale
Standard Deviation 6.24
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.7 Units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 5 Day 1
|
0.5 Units on a scale
Standard Deviation 3.54
|
0.5 Units on a scale
Standard Deviation 0.71
|
1.5 Units on a scale
Standard Deviation 2.12
|
0.3 Units on a scale
Standard Deviation 1.25
|
-0.2 Units on a scale
Standard Deviation 1.72
|
0.5 Units on a scale
Standard Deviation 6.36
|
—
|
4.7 Units on a scale
Standard Deviation 8.14
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 6 Day 1
|
2.5 Units on a scale
Standard Deviation 2.12
|
0.5 Units on a scale
Standard Deviation 0.71
|
1.0 Units on a scale
Standard Deviation 1.41
|
-0.4 Units on a scale
Standard Deviation 2.70
|
0.3 Units on a scale
Standard Deviation 0.90
|
2.0 Units on a scale
Standard Deviation 4.24
|
—
|
4.3 Units on a scale
Standard Deviation 5.86
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.3 Units on a scale
Standard Deviation 2.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 7 Day 1
|
2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.5 Units on a scale
Standard Deviation 0.71
|
1.5 Units on a scale
Standard Deviation 2.12
|
-0.1 Units on a scale
Standard Deviation 1.21
|
0.4 Units on a scale
Standard Deviation 0.90
|
3.0 Units on a scale
Standard Deviation 4.24
|
—
|
4.7 Units on a scale
Standard Deviation 8.33
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.7 Units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 8 Day 1
|
-4.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.5 Units on a scale
Standard Deviation 0.71
|
1.5 Units on a scale
Standard Deviation 2.12
|
-0.1 Units on a scale
Standard Deviation 2.34
|
0.2 Units on a scale
Standard Deviation 1.34
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
3.0 Units on a scale
Standard Deviation 7.81
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 9 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.0 Units on a scale
Standard Deviation 2.31
|
0.3 Units on a scale
Standard Deviation 2.10
|
6.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
6.0 Units on a scale
Standard Deviation 8.49
|
—
|
-0.3 Units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 11 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.3 Units on a scale
Standard Deviation 1.70
|
-0.2 Units on a scale
Standard Deviation 1.53
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
7.0 Units on a scale
Standard Deviation 8.49
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 12 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
-0.6 Units on a scale
Standard Deviation 2.19
|
-0.2 Units on a scale
Standard Deviation 2.33
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
6.5 Units on a scale
Standard Deviation 9.19
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.7 Units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 13 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.8 Units on a scale
Standard Deviation 1.79
|
0.5 Units on a scale
Standard Deviation 2.22
|
3.0 Units on a scale
Standard Deviation 4.24
|
—
|
5.5 Units on a scale
Standard Deviation 7.78
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 14 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
-0.3 Units on a scale
Standard Deviation 3.20
|
0.3 Units on a scale
Standard Deviation 0.79
|
2.5 Units on a scale
Standard Deviation 3.54
|
—
|
6.0 Units on a scale
Standard Deviation 8.49
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 15 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
-1.7 Units on a scale
Standard Deviation 5.43
|
0.1 Units on a scale
Standard Deviation 1.36
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.3 Units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 16 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 1.41
|
—
|
-0.2 Units on a scale
Standard Deviation 2.49
|
-0.2 Units on a scale
Standard Deviation 1.99
|
1.5 Units on a scale
Standard Deviation 6.36
|
—
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 17 Day 1
|
—
|
-2.0 Units on a scale
Standard Deviation 2.83
|
—
|
0.6 Units on a scale
Standard Deviation 1.95
|
0.1 Units on a scale
Standard Deviation 1.17
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
-3.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.3 Units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 18 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.8 Units on a scale
Standard Deviation 1.79
|
0.0 Units on a scale
Standard Deviation 1.73
|
3.0 Units on a scale
Standard Deviation 4.24
|
—
|
-2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 20 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.0 Units on a scale
Standard Deviation 1.41
|
0.7 Units on a scale
Standard Deviation 2.12
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 21 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.0 Units on a scale
Standard Deviation 1.41
|
0.1 Units on a scale
Standard Deviation 2.09
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 22 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.4 Units on a scale
Standard Deviation 1.52
|
0.1 Units on a scale
Standard Deviation 1.45
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.3 Units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 23 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.0 Units on a scale
Standard Deviation 1.41
|
0.1 Units on a scale
Standard Deviation 1.81
|
1.5 Units on a scale
Standard Deviation 3.54
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-2.3 Units on a scale
Standard Deviation 4.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 24 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
-0.4 Units on a scale
Standard Deviation 0.89
|
0.6 Units on a scale
Standard Deviation 0.74
|
1.5 Units on a scale
Standard Deviation 4.95
|
—
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 25 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.8 Units on a scale
Standard Deviation 1.79
|
-0.9 Units on a scale
Standard Deviation 2.27
|
2.5 Units on a scale
Standard Deviation 4.95
|
—
|
-2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 26 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.8 Units on a scale
Standard Deviation 1.79
|
-0.4 Units on a scale
Standard Deviation 2.77
|
2.0 Units on a scale
Standard Deviation 4.24
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.3 Units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 27 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.8 Units on a scale
Standard Deviation 1.79
|
-0.1 Units on a scale
Standard Deviation 2.67
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-1.0 Units on a scale
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 29 Day 1
|
—
|
-1.5 Units on a scale
Standard Deviation 2.12
|
—
|
0.5 Units on a scale
Standard Deviation 1.73
|
0.1 Units on a scale
Standard Deviation 1.81
|
3.5 Units on a scale
Standard Deviation 3.54
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 34 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.3 Units on a scale
Standard Deviation 0.50
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 35 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.3 Units on a scale
Standard Deviation 0.50
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 37 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
3.5 Units on a scale
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 38 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation 0.00
|
3.0 Units on a scale
Standard Deviation 2.83
|
—
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 39 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.5 Units on a scale
Standard Deviation 0.71
|
3.5 Units on a scale
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 40 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 41 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
1.5 Units on a scale
Standard Deviation 6.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 42 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 43 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
4.0 Units on a scale
Standard Deviation 4.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 45 Day 1
|
—
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 46 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 47 Day 1
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 48 Day 1
|
—
|
-3.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 49 Day 1
|
—
|
0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 50 Day 1
|
—
|
-3.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 51 Day 1
|
—
|
-0.5 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Cycle 52 Day 1
|
—
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
End of treatment
|
-8.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
0.7 Units on a scale
Standard Deviation 1.15
|
-2.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
-2.3 Units on a scale
Standard Deviation 5.19
|
—
|
—
|
—
|
-15.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the first documentation of objective tumor response (CR or PR) (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=27 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=21 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=34 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=26 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=13 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=18 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Tumor Response (TTR) and Intracranial TTR (Phase 2 and DDI Sub-study)
TTR
|
1.4 Months
Interval 1.2 to 5.4
|
1.4 Months
Interval 1.2 to 18.0
|
1.4 Months
Interval 1.1 to 16.6
|
2.6 Months
Interval 1.2 to 16.4
|
1.4 Months
Interval 1.2 to 9.3
|
1.4 Months
Interval 1.2 to 11.0
|
—
|
1.4 Months
Interval 1.3 to 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Tumor Response (TTR) and Intracranial TTR (Phase 2 and DDI Sub-study)
Intracranial TTR
|
2.1 Months
Interval 1.2 to 2.8
|
1.4 Months
Interval 1.2 to 1.5
|
1.4 Months
Interval 1.1 to 5.7
|
1.7 Months
Interval 1.2 to 17.5
|
1.4 Months
Interval 1.2 to 10.6
|
2.0 Months
Interval 1.1 to 4.2
|
—
|
1.4 Months
Interval 1.2 to 28.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of PD or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=27 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=21 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=34 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=26 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=13 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=18 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) and Intracranial DOR (Phase 2 and DDI Substudy)
Intra-cranial DOR
|
NA Months
Interval 8.28 to
Median and Upper limit could not be calculated due to insufficient number of participants with events..
|
NA Months
Interval 20.99 to
Median and Upper limit could not be calculated due to insufficient number of participants with events.
|
37.12 Months
Interval 8.38 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
14.52 Months
Interval 11.07 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
10.32 Months
Interval 6.9 to 14.98
|
NA Months
Interval 2.76 to
Median and upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
17.62 Months
Interval 4.99 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DOR) and Intracranial DOR (Phase 2 and DDI Substudy)
DOR
|
17.16 Months
Interval 12.45 to 35.09
|
16.56 Months
Interval 4.2 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
11.10 Months
Interval 5.55 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
15.08 Months
Interval 5.55 to 26.28
|
7.03 Months
Interval 4.17 to 11.01
|
5.19 Months
Interval 4.17 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
19.61 Months
Interval 11.1 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed CR, confirmed PR, or stable disease (SD). CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. SD= when neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD is observed, taking as reference the smallest sum diameters while on study. Intracranial assessment was only performed for participants CNS metastases. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=60 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=65 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Disease Control and Intracranial Disease Control at Week 12 and 24 (Phase 2 and DDI Substudy)
Disease control rate at Week 12
|
93.3 Percentage of participants
Interval 77.9 to 99.2
|
85.2 Percentage of participants
Interval 66.3 to 95.8
|
68.3 Percentage of participants
Interval 55.0 to 79.7
|
64.6 Percentage of participants
Interval 51.8 to 76.1
|
50.0 Percentage of participants
Interval 34.9 to 65.1
|
56.3 Percentage of participants
Interval 37.7 to 73.6
|
—
|
66.0 Percentage of participants
Interval 50.7 to 79.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Disease Control and Intracranial Disease Control at Week 12 and 24 (Phase 2 and DDI Substudy)
Disease control rate at Week 24
|
83.3 Percentage of participants
Interval 65.3 to 94.4
|
63.0 Percentage of participants
Interval 42.4 to 80.6
|
51.7 Percentage of participants
Interval 38.4 to 64.8
|
49.2 Percentage of participants
Interval 36.6 to 61.9
|
32.6 Percentage of participants
Interval 19.5 to 48.0
|
34.4 Percentage of participants
Interval 18.6 to 53.2
|
—
|
48.9 Percentage of participants
Interval 34.1 to 63.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Disease Control and Intracranial Disease Control at Week 12 and 24 (Phase 2 and DDI Substudy)
Intra-cranial disease control rate at Week 12
|
87.5 Percentage of participants
Interval 47.3 to 99.7
|
94.1 Percentage of participants
Interval 71.3 to 99.9
|
75.8 Percentage of participants
Interval 57.7 to 88.9
|
75.6 Percentage of participants
Interval 60.5 to 87.1
|
67.6 Percentage of participants
Interval 50.2 to 82.0
|
56.3 Percentage of participants
Interval 29.9 to 80.2
|
—
|
72.0 Percentage of participants
Interval 50.6 to 87.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Disease Control and Intracranial Disease Control at Week 12 and 24 (Phase 2 and DDI Substudy)
Intra-cranial disease control rate at Week 24
|
75.0 Percentage of participants
Interval 34.9 to 96.8
|
70.6 Percentage of participants
Interval 44.0 to 89.7
|
60.6 Percentage of participants
Interval 42.1 to 77.1
|
62.2 Percentage of participants
Interval 46.5 to 76.2
|
48.6 Percentage of participants
Interval 31.9 to 65.6
|
43.8 Percentage of participants
Interval 19.8 to 70.1
|
—
|
52.0 Percentage of participants
Interval 31.3 to 72.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the date of progression (maximum of 7.5 years for Phase 2)Population: ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. As planned in SAP, this outcome measure was not analyzed for EXP-1 and EXP-6 groups. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
TTP on the last prior therapy was defined as time from the first dose date of the last prior treatment regimen to the date of progression. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=27 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=60 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=65 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=46 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression on the Last Prior Therapy (Phase 2)
Prior systemic therapy before PF-06463922
|
11.5 Months
Interval 7.2 to 19.6
|
12.8 Months
Interval 10.9 to 16.9
|
10.2 Months
Interval 7.6 to 15.9
|
3.7 Months
Interval 2.1 to 6.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Progression on the Last Prior Therapy (Phase 2)
Prior ALK+/ROS1+ TKI treatment
|
11.5 Months
Interval 7.2 to 19.6
|
13.8 Months
Interval 11.2 to 18.1
|
12.1 Months
Interval 7.9 to 16.4
|
3.7 Months
Interval 2.1 to 6.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Progression on the Last Prior Therapy (Phase 2)
Prior systemic therapy other than ALK+/ROS1+ TKI
|
19.6 Months
Interval 16.1 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
8.5 Months
Interval 5.0 to 12.6
|
5.0 Months
Interval 3.1 to 10.0
|
5.6 Months
Interval 3.5 to 11.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the first documentation of objective PD (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: ITT analysis set was used for TTP determination and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; ITT participants with CNS metastases were analyzed for intracranial TTP.
Time to progression (TTP) was defined as the time from the first dose of study treatment to the first documentation of objective PD. Intracranial TTP was defined as the time from the first dose of study treatment to the date of the first documentation of objective progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=60 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=65 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Tumor Progression (TTP) and Intracranial TTP (Phase 2 and DDI Substudy)
TTP
|
17.7 Months
Interval 12.5 to 40.5
|
20.6 Months
Interval 5.5 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
8.2 Months
Interval 5.5 to 12.5
|
8.4 Months
Interval 5.6 to 13.7
|
5.6 Months
Interval 4.0 to 8.3
|
5.7 Months
Interval 4.1 to 8.3
|
—
|
12.5 Months
Interval 8.2 to 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Tumor Progression (TTP) and Intracranial TTP (Phase 2 and DDI Substudy)
Intracranial TTP
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Interval 15.0 to
Median and Upper limit could not be calculated due to insufficient number of participants with events.
|
22.1 Months
Interval 15.7 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
16.4 Months
Interval 12.7 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
NA Months
Interval 6.9 to
Median and Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
NA Months
Interval 34.5 to
Median and Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment until first event of CNS progression (maximum of 7.5 years for Phase 2)Population: The ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
Probability of first event being CNS progression, non-CNS progression, or death was evaluated with competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to analysis set. Time to first event being Competing Event (either "CNS progression" or "non CNS progression" or "Death") = time from first dose until date of that specific event. Participants not known to have any of Competing Events were censored on date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as competing cause of failure for analysis of other type of events. For each type of event, cumulative incidence function corresponding to nearest time point preceding 1 year is presented. PD:20% or more increase in SLD of target lesion relative to baseline or smallest SLD (nadir) recorded since first dose. SLD must demonstrate absolute increase of atleast 5mm(\>=5 mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=274 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)
CNS progression
|
0.179 Probability of events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)
Non CNS progression
|
0.325 Probability of events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)
Death
|
0.055 Probability of events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to first documentation of objective PD or death due to any cause, whichever came first (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
PFS was defined as the time from the first dose of study treatment to the first documentation of objective PD or to death on study due to any cause, whichever came first. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=60 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=65 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) (Phase 2 and DDI Substudy)
|
16.6 Months
Interval 11.8 to 28.3
|
20.6 Months
Interval 5.5 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
6.9 Months
Interval 5.5 to 11.0
|
7.3 Months
Interval 4.2 to 11.1
|
5.5 Months
Interval 3.9 to 8.2
|
5.7 Months
Interval 4.0 to 7.1
|
—
|
9.9 Months
Interval 5.5 to 21.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment until date of death (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=60 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=65 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (Phase 2 and DDI Substudy)
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
52.5 Months
Interval 24.4 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
NA Months
Interval 38.5 to
Median and upper limit could not be calculated due to insufficient number of participants with events.
|
18.7 Months
Interval 15.1 to 34.1
|
20.4 Months
Interval 10.5 to 31.6
|
19.8 Months
Interval 11.1 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
49.7 Months
Interval 21.0 to
Upper limit could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number Analyzed" signifies participants analyzed for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=22 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)
Day -7
|
695.2 ng/mL
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)
Cycle 1 Day 15
|
576.5 ng/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Number Analyzed" signifies participants analyzed for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Tmax of PF-06463922 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=22 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-06463922 (Phase 2)
Day -7
|
1.15 Hours
Interval 0.5 to 4.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time for Cmax (Tmax) of PF-06463922 (Phase 2)
Cycle 1 Day 15
|
1.96 Hours
Interval 0.5 to 22.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, 'Overall Number of Participants Analyzed' signifies participants analyzed for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=16 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 (Phase 2)
|
9088 ng*hour/mL
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, 'Number Analyzed' signifies participants evaluable for specified row.
Tau refers to the dosing interval, and it equals to 24 hours for QD dosing which was adopted in Phase 2. AUCtau was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=22 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2)
Day -7
|
5308 ng*hour/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2)
Cycle 1 Day 15
|
5650 ng*hour/mL
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, 'Number Analyzed' signifies participants evaluable for specified row.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=22 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2)
Day -7
|
11.01 Liter/hour
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2)
Cycle 1 Day 15
|
17.70 Liter/hour
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf\*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=16 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06463922 (Phase 2)
|
351.5 Liters
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=16 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life of PF-06463922 (Phase 2)
|
23.58 Hours
Standard Deviation 9.3743
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Rac was calculated as Day 15 AUCtau/Day -7 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen which was adopted in Phase 2).
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=20 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 2)
|
1.082 Ratio
Standard Deviation 0.42701
|
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15Population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen which was adopted in Phase 2), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=14 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 2)
|
0.6577 Ratio
Standard Deviation 0.28627
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (up to 28 days)Population: CNA peripheral blood analysis set included all participants of the ITT analysis set who had at least 1 molecular biomarker assayed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Plasma CNA samples were analyzed for ALK kinase domain mutations by Next Generation Sequencing (NGS). Number of participants with one or more ALK mutations is presented.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=59 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=61 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 2)
|
0 Participants
|
6 Participants
|
8 Participants
|
17 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (up to 28 days)Population: Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).
Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=29 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=58 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=63 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=44 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 2)
|
0 Participants
|
7 Participants
|
8 Participants
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=55 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=60 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=43 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=41 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in pain
|
7 Participants
|
2 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in dyspnea
|
16 Participants
|
10 Participants
|
10 Participants
|
23 Participants
|
14 Participants
|
9 Participants
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in insomnia
|
20 Participants
|
8 Participants
|
18 Participants
|
30 Participants
|
21 Participants
|
12 Participants
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in insomnia
|
9 Participants
|
13 Participants
|
28 Participants
|
22 Participants
|
16 Participants
|
15 Participants
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in insomnia
|
1 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for insomnia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in appetite loss
|
14 Participants
|
4 Participants
|
18 Participants
|
29 Participants
|
22 Participants
|
10 Participants
|
—
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in appetite loss
|
16 Participants
|
22 Participants
|
36 Participants
|
26 Participants
|
21 Participants
|
20 Participants
|
—
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in appetite loss
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for appetite loss
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in constipation
|
10 Participants
|
5 Participants
|
9 Participants
|
16 Participants
|
11 Participants
|
10 Participants
|
—
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in diarrhea
|
18 Participants
|
21 Participants
|
40 Participants
|
39 Participants
|
27 Participants
|
21 Participants
|
—
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for diarrhea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in financial difficulties
|
10 Participants
|
6 Participants
|
11 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
—
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in financial difficulties
|
17 Participants
|
19 Participants
|
34 Participants
|
38 Participants
|
22 Participants
|
16 Participants
|
—
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in emotional functioning
|
13 Participants
|
12 Participants
|
13 Participants
|
20 Participants
|
17 Participants
|
10 Participants
|
—
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in global QoL
|
17 Participants
|
11 Participants
|
18 Participants
|
25 Participants
|
17 Participants
|
12 Participants
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in global QoL
|
10 Participants
|
12 Participants
|
24 Participants
|
22 Participants
|
16 Participants
|
18 Participants
|
—
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in global QoL
|
3 Participants
|
3 Participants
|
13 Participants
|
13 Participants
|
10 Participants
|
2 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for global QoL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in physical functioning
|
11 Participants
|
8 Participants
|
13 Participants
|
24 Participants
|
8 Participants
|
5 Participants
|
—
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in physical functioning
|
13 Participants
|
17 Participants
|
38 Participants
|
24 Participants
|
25 Participants
|
23 Participants
|
—
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in physical functioning
|
6 Participants
|
1 Participants
|
4 Participants
|
12 Participants
|
10 Participants
|
4 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for physical functioning
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in role functioning
|
12 Participants
|
7 Participants
|
15 Participants
|
25 Participants
|
18 Participants
|
10 Participants
|
—
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in role functioning
|
9 Participants
|
16 Participants
|
33 Participants
|
18 Participants
|
13 Participants
|
15 Participants
|
—
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in role functioning
|
9 Participants
|
3 Participants
|
7 Participants
|
17 Participants
|
12 Participants
|
7 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for role functioning
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in cognitive functioning
|
12 Participants
|
14 Participants
|
36 Participants
|
34 Participants
|
19 Participants
|
11 Participants
|
—
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in cognitive functioning
|
9 Participants
|
8 Participants
|
14 Participants
|
14 Participants
|
12 Participants
|
12 Participants
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for cognitive functioning
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in social functioning
|
14 Participants
|
7 Participants
|
16 Participants
|
20 Participants
|
11 Participants
|
13 Participants
|
—
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in social functioning
|
11 Participants
|
16 Participants
|
33 Participants
|
29 Participants
|
21 Participants
|
13 Participants
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in social functioning
|
5 Participants
|
3 Participants
|
6 Participants
|
11 Participants
|
11 Participants
|
6 Participants
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in emotional functioning
|
13 Participants
|
14 Participants
|
32 Participants
|
34 Participants
|
20 Participants
|
20 Participants
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in emotional functioning
|
4 Participants
|
0 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for emotional functioning
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in cognitive functioning
|
9 Participants
|
4 Participants
|
5 Participants
|
12 Participants
|
12 Participants
|
9 Participants
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for social functioning
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in constipation
|
6 Participants
|
2 Participants
|
13 Participants
|
11 Participants
|
3 Participants
|
10 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in fatigue
|
18 Participants
|
14 Participants
|
22 Participants
|
28 Participants
|
26 Participants
|
17 Participants
|
—
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for constipation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in diarrhea
|
5 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in diarrhea
|
7 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in fatigue
|
8 Participants
|
11 Participants
|
25 Participants
|
23 Participants
|
9 Participants
|
9 Participants
|
—
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in fatigue
|
4 Participants
|
1 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in nausea and vomiting
|
8 Participants
|
5 Participants
|
10 Participants
|
16 Participants
|
13 Participants
|
6 Participants
|
—
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in nausea and vomiting
|
22 Participants
|
21 Participants
|
44 Participants
|
39 Participants
|
28 Participants
|
24 Participants
|
—
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in nausea and vomiting
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for nausea and vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Improved in pain
|
13 Participants
|
10 Participants
|
20 Participants
|
23 Participants
|
19 Participants
|
14 Participants
|
—
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in pain
|
10 Participants
|
14 Participants
|
25 Participants
|
28 Participants
|
19 Participants
|
13 Participants
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in dyspnea
|
10 Participants
|
14 Participants
|
33 Participants
|
22 Participants
|
18 Participants
|
15 Participants
|
—
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in dyspnea
|
4 Participants
|
2 Participants
|
12 Participants
|
15 Participants
|
11 Participants
|
8 Participants
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for dyspnea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Stable in constipation
|
14 Participants
|
19 Participants
|
33 Participants
|
33 Participants
|
29 Participants
|
12 Participants
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Missing for financial difficulties
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Worsened in financial difficulties
|
3 Participants
|
1 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
7 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=55 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=60 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=43 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=41 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in dyspnea
|
16 Participants
|
18 Participants
|
36 Participants
|
25 Participants
|
21 Participants
|
18 Participants
|
—
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in dyspnea
|
3 Participants
|
3 Participants
|
10 Participants
|
14 Participants
|
9 Participants
|
8 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-dyspnea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in coughing
|
18 Participants
|
9 Participants
|
22 Participants
|
26 Participants
|
18 Participants
|
16 Participants
|
—
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in coughing
|
9 Participants
|
13 Participants
|
26 Participants
|
28 Participants
|
15 Participants
|
15 Participants
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in coughing
|
3 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
1 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-coughing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in hemoptysis
|
4 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in hemoptysis
|
24 Participants
|
25 Participants
|
47 Participants
|
52 Participants
|
34 Participants
|
31 Participants
|
—
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in hemoptysis
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-hemoptysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in sore mouth
|
0 Participants
|
2 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in sore mouth
|
25 Participants
|
20 Participants
|
44 Participants
|
41 Participants
|
33 Participants
|
26 Participants
|
—
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in sore mouth
|
5 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
2 Participants
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-sore mouth
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in dysphagia
|
3 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in dysphagia
|
23 Participants
|
24 Participants
|
46 Participants
|
48 Participants
|
33 Participants
|
27 Participants
|
—
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in dysphagia
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-dysphagia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in peripheral neuropathy
|
4 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in peripheral neuropathy
|
10 Participants
|
13 Participants
|
27 Participants
|
33 Participants
|
22 Participants
|
16 Participants
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in peripheral neuropathy
|
16 Participants
|
8 Participants
|
19 Participants
|
22 Participants
|
14 Participants
|
7 Participants
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-peripheral neuropathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in alopecia
|
2 Participants
|
1 Participants
|
2 Participants
|
10 Participants
|
10 Participants
|
4 Participants
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in alopecia
|
18 Participants
|
22 Participants
|
41 Participants
|
40 Participants
|
24 Participants
|
21 Participants
|
—
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in alopecia
|
10 Participants
|
3 Participants
|
12 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-alopecia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in chest pain
|
11 Participants
|
7 Participants
|
13 Participants
|
18 Participants
|
14 Participants
|
13 Participants
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in chest pain
|
17 Participants
|
17 Participants
|
35 Participants
|
33 Participants
|
25 Participants
|
17 Participants
|
—
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in chest pain
|
2 Participants
|
2 Participants
|
6 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-chest pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in arm or shoulder pain
|
10 Participants
|
5 Participants
|
14 Participants
|
14 Participants
|
12 Participants
|
9 Participants
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in arm or shoulder pain
|
15 Participants
|
19 Participants
|
30 Participants
|
36 Participants
|
21 Participants
|
19 Participants
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in arm or shoulder pain
|
5 Participants
|
2 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
4 Participants
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing- arm or shoulder pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in pain in other parts
|
9 Participants
|
6 Participants
|
17 Participants
|
20 Participants
|
15 Participants
|
9 Participants
|
—
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Stable in pain in other parts
|
14 Participants
|
15 Participants
|
23 Participants
|
24 Participants
|
9 Participants
|
10 Participants
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Worsened in pain in other parts
|
7 Participants
|
5 Participants
|
15 Participants
|
16 Participants
|
17 Participants
|
12 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Missing-Pain in other parts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Improved in dyspnea
|
11 Participants
|
5 Participants
|
9 Participants
|
21 Participants
|
12 Participants
|
6 Participants
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.
AE: any untoward medical occurrence in clinical investigation participant administered a product or medical device, regardless of causal relationship to study treatment. Treatment-emergent AEs (TEAEs): AEs which occurred for first time during effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs): any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of ability to conduction normal life function). AEs included SAEs and non-serious AEs. Severity was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.Grade1: mild, Grade2: moderate, Grade3: severe, Grade4: Life threatening consequences; urgent intervention indicated, Grade 5: death related to AE.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=46 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
SAEs (all causality)
|
3 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
15 Participants
|
11 Participants
|
34 Participants
|
31 Participants
|
23 Participants
|
21 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
Grade 3 or 4 (all causality)
|
3 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
22 Participants
|
22 Participants
|
43 Participants
|
50 Participants
|
36 Participants
|
36 Participants
|
24 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
Grade 5 (all causality)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
11 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
Grade 5 (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
AEs (all causality)
|
3 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
17 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
30 Participants
|
27 Participants
|
59 Participants
|
65 Participants
|
46 Participants
|
47 Participants
|
32 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
AEs (treatment-related)
|
3 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
16 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
30 Participants
|
27 Participants
|
56 Participants
|
61 Participants
|
43 Participants
|
45 Participants
|
31 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
SAEs (treatment-related)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)
Grade 3 or 4 (treatment-related)
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
13 Participants
|
15 Participants
|
31 Participants
|
31 Participants
|
22 Participants
|
25 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922. Here 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. Hematology parameters with any abnormalities were reported in this outcome measure.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=64 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=45 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
White blood cell decreased
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
13 Participants
|
8 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
Anemia
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
16 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
24 Participants
|
22 Participants
|
51 Participants
|
52 Participants
|
35 Participants
|
34 Participants
|
25 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
Hemoglobin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
Lymphocyte count decreased
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
12 Participants
|
14 Participants
|
30 Participants
|
31 Participants
|
21 Participants
|
26 Participants
|
15 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
Lymphocyte count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
Neutrophil count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
Platelet count decreased
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
18 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable for specified rows.
Chemistry evaluation included alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, creatine phosphokinase (CPK), creatinine, gamma-glutamyl transferase (GGT), calcium, sodium, potassium, magnesium, albumin, glucose (non-fasted), albumin, phosphorus or phosphate, serum amylase and lipase.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=64 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=45 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
ALT increased
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
13 Participants
|
15 Participants
|
25 Participants
|
25 Participants
|
16 Participants
|
15 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Alkaline phosphatase increased
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
13 Participants
|
29 Participants
|
27 Participants
|
25 Participants
|
14 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
AST increased
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
16 Participants
|
15 Participants
|
36 Participants
|
33 Participants
|
21 Participants
|
18 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
CPK increased
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Creatinine increased
|
3 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
13 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
28 Participants
|
22 Participants
|
40 Participants
|
48 Participants
|
34 Participants
|
37 Participants
|
20 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
GGT increased
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hyponatremia
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
9 Participants
|
15 Participants
|
23 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypophosphatemia
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
9 Participants
|
23 Participants
|
19 Participants
|
8 Participants
|
15 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Lipase increased
|
3 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
7 Participants
|
14 Participants
|
16 Participants
|
15 Participants
|
18 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Serum amylase increased
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
13 Participants
|
6 Participants
|
18 Participants
|
20 Participants
|
11 Participants
|
15 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hyperglycemia
|
3 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
17 Participants
|
18 Participants
|
37 Participants
|
48 Participants
|
34 Participants
|
31 Participants
|
23 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hyperkalemia
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
13 Participants
|
21 Participants
|
13 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypermagnesemia
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypernatremia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypoalbuminemia
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
19 Participants
|
20 Participants
|
37 Participants
|
43 Participants
|
32 Participants
|
29 Participants
|
18 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypocalcemia
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
16 Participants
|
9 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypoglycemia
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypokalemia
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
11 Participants
|
2 Participants
|
10 Participants
|
12 Participants
|
8 Participants
|
14 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Chemistry
Hypomagnesemia
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
9 Participants
|
23 Participants
|
20 Participants
|
16 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable for specified rows.
Coagulation evaluation included activated partial thromboplastin time, international normalized ratio (INR), and prothrombin time. Lipid evaluation included Cholesterol and triglycerides.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=64 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=45 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=46 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Coagulation, Lipids and Urinalysis
Activated partial thromboplastin time prolonged
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Coagulation, Lipids and Urinalysis
Hypertriglyceridemia
|
0 Participants
|
2 Participants
|
2 Participants
|
11 Participants
|
16 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
30 Participants
|
26 Participants
|
56 Participants
|
61 Participants
|
45 Participants
|
43 Participants
|
31 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Coagulation, Lipids and Urinalysis
Cholesterol high
|
2 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
16 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
30 Participants
|
26 Participants
|
58 Participants
|
64 Participants
|
45 Participants
|
44 Participants
|
31 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Coagulation, Lipids and Urinalysis
INR increased
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Coagulation, Lipids and Urinalysis
Prothrombin time
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable for specified row.
Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position. Body weight was also measured.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=45 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=46 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Sitting pulse rate <50 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in sitting SBP >=40 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in sitting SBP >=60 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Decrease in sitting SBP >=40 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Decrease in sitting SBP >=60 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in sitting DBP >=20 mmHg
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
12 Participants
|
21 Participants
|
15 Participants
|
15 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in sitting DBP >=40 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Decrease in sitting DBP >=20 mmHg
|
2 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
15 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Decrease in sitting DBP >=40 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Sitting pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in sitting pulse rate >=30 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
14 Participants
|
19 Participants
|
17 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Decrease in sitting pulse rate >=30 bpm
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in weight: 10% to <20%
|
1 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
14 Participants
|
17 Participants
|
15 Participants
|
11 Participants
|
14 Participants
|
9 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Increase in weight: >=20%
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
12 Participants
|
2 Participants
|
10 Participants
|
16 Participants
|
9 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
Decrease in weight >=10%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.
Left Ventricular Ejection Fraction (LVEF) was determined by echocardiogram. Baseline was defined as the measurement prior to the first dose of study treatment.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=46 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Percent in Left Ventricular Ejection Fraction (LVEF) (Phase 1, Phase 2 and DDI Sub-study)
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
13 Participants
|
14 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.
Triplicate 12-lead electrocardiograms (ECGs) were performed approximately 2 minutes apart to determine mean QTc interval (QT interval corrected for heart rate). QT interval was corrected for heart rate using Fridericia's formula to provide QTcF. Absolute values and changes from baseline were summarized according to pre-defined criteria. Baseline was defined as the last evaluation on or prior to the first dose of study treatment.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=3 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=3 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=12 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=17 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=3 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 Participants
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
n=30 Participants
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=46 Participants
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 Participants
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
n=32 Participants
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
QTcF: 480 to <500 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
QTcF: 450 to <480 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
11 Participants
|
9 Participants
|
13 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
QTcF: >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
QTcF Increase: 30 to <60 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
8 Participants
|
18 Participants
|
20 Participants
|
7 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
QTcF: >=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.
The Columbia Suicide Severity Rating Scale (C-SSRS) was used to analyze participants' suicidal ideation and behavior, and it is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events and provides a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide. Maximum score of 4 or 5 indicates maximum suicidal ideation and minimum score of "0" indicates no suicidal ideation.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=26 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=24 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=52 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=43 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=30 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=25 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation and Suicidal Behavior (Phase 2)
Suicidal behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation and Suicidal Behavior (Phase 2)
Suicidal ideation
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
The Beck Depression Inventory (BDI)-II is a 21-item self-report scale, with each item rated by participants on a 4-point scale (ranging from 0-3, where 0 indicated lowest depression and 3 indicated severe depression). The scale includes items capturing mood, (loss of pleasure, sadness, and irritability), suicidal ideation, and cognitive signs (punitive thoughts, self-criticism, self-dislike, pessimism, and poor concentration) as well as somatic signs (appetite, sleep, fatigue and libido). Scores were obtained by adding up the total points from the series of answers. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=24 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=24 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=53 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=41 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=28 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=26 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 10 Day 1
|
-3.09 Units on a scale
Interval -5.38 to -0.8
|
-4.92 Units on a scale
Interval -7.28 to -2.55
|
-1.94 Units on a scale
Interval -3.54 to -0.34
|
-4.27 Units on a scale
Interval -6.14 to -2.39
|
-2.97 Units on a scale
Interval -5.29 to -0.66
|
—
|
—
|
-0.19 Units on a scale
Interval -2.6 to 2.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 24 Day 1
|
-7.31 Units on a scale
Interval -11.66 to -2.96
|
-5.63 Units on a scale
Interval -10.0 to -1.26
|
-2.88 Units on a scale
Interval -7.04 to 1.28
|
-3.89 Units on a scale
Interval -8.1 to 0.32
|
—
|
—
|
—
|
2.27 Units on a scale
Interval -2.06 to 6.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 2 Day 1
|
-2.59 Units on a scale
Interval -4.82 to -0.37
|
-3.27 Units on a scale
Interval -5.52 to -1.01
|
-2.26 Units on a scale
Interval -3.77 to -0.76
|
-2.17 Units on a scale
Interval -3.89 to -0.46
|
-1.52 Units on a scale
Interval -3.6 to 0.56
|
—
|
—
|
-2.43 Units on a scale
Interval -4.57 to -0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 3 Day 1
|
-3.34 Units on a scale
Interval -5.57 to -1.12
|
-3.18 Units on a scale
Interval -5.43 to -0.93
|
-3.03 Units on a scale
Interval -4.55 to -1.51
|
-3.10 Units on a scale
Interval -4.85 to -1.35
|
-0.46 Units on a scale
Interval -2.61 to 1.69
|
—
|
—
|
-1.24 Units on a scale
Interval -3.37 to 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 4 Day 1
|
-3.84 Units on a scale
Interval -6.07 to -1.62
|
-4.10 Units on a scale
Interval -6.38 to -1.82
|
-2.59 Units on a scale
Interval -4.14 to -1.05
|
-1.95 Units on a scale
Interval -3.72 to -0.19
|
-1.19 Units on a scale
Interval -3.38 to 1.01
|
—
|
—
|
-1.94 Units on a scale
Interval -4.12 to 0.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 5 Day 1
|
-4.47 Units on a scale
Interval -6.69 to -2.24
|
-3.96 Units on a scale
Interval -6.27 to -1.66
|
-2.75 Units on a scale
Interval -4.33 to -1.16
|
-3.03 Units on a scale
Interval -4.82 to -1.25
|
-1.51 Units on a scale
Interval -3.74 to 0.72
|
—
|
—
|
-1.25 Units on a scale
Interval -3.46 to 0.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 6 Day 1
|
-3.51 Units on a scale
Interval -5.73 to -1.28
|
-4.25 Units on a scale
Interval -6.56 to -1.94
|
-3.31 Units on a scale
Interval -4.9 to -1.72
|
-3.79 Units on a scale
Interval -5.61 to -1.98
|
-0.42 Units on a scale
Interval -2.64 to 1.81
|
—
|
—
|
-0.29 Units on a scale
Interval -2.54 to 1.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 8 Day 1
|
-4.17 Units on a scale
Interval -6.41 to -1.92
|
-4.86 Units on a scale
Interval -7.23 to -2.5
|
-2.26 Units on a scale
Interval -3.86 to -0.66
|
-4.06 Units on a scale
Interval -5.9 to -2.22
|
-1.09 Units on a scale
Interval -3.34 to 1.17
|
—
|
—
|
0.17 Units on a scale
Interval -2.1 to 2.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 12 Day 1
|
-3.95 Units on a scale
Interval -6.3 to -1.61
|
-5.60 Units on a scale
Interval -7.97 to -3.24
|
-0.72 Units on a scale
Interval -2.4 to 0.95
|
-4.80 Units on a scale
Interval -6.83 to -2.77
|
-1.94 Units on a scale
Interval -4.29 to 0.42
|
—
|
—
|
-1.40 Units on a scale
Interval -3.81 to 1.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 14 Day 1
|
-3.81 Units on a scale
Interval -6.18 to -1.43
|
-5.80 Units on a scale
Interval -8.35 to -3.25
|
-2.58 Units on a scale
Interval -4.41 to -0.76
|
-4.29 Units on a scale
Interval -6.41 to -2.17
|
-1.73 Units on a scale
Interval -4.4 to 0.94
|
—
|
—
|
-0.08 Units on a scale
Interval -2.59 to 2.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 16 Day 1
|
-1.75 Units on a scale
Interval -4.4 to 0.89
|
-4.61 Units on a scale
Interval -7.51 to -1.71
|
-2.15 Units on a scale
Interval -4.35 to 0.06
|
-4.65 Units on a scale
Interval -6.9 to -2.41
|
-2.22 Units on a scale
Interval -5.5 to 1.07
|
—
|
—
|
0.03 Units on a scale
Interval -2.65 to 2.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 18 Day 1
|
-4.49 Units on a scale
Interval -7.49 to -1.49
|
-7.02 Units on a scale
Interval -10.59 to -3.46
|
-1.96 Units on a scale
Interval -4.22 to 0.31
|
-2.86 Units on a scale
Interval -5.21 to -0.51
|
-1.11 Units on a scale
Interval -8.25 to 6.03
|
—
|
—
|
1.88 Units on a scale
Interval -1.66 to 5.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 20 Day 1
|
-5.01 Units on a scale
Interval -8.55 to -1.46
|
-5.17 Units on a scale
Interval -9.06 to -1.29
|
-1.82 Units on a scale
Interval -4.7 to 1.06
|
-3.63 Units on a scale
Interval -6.31 to -0.95
|
—
|
—
|
—
|
1.88 Units on a scale
Interval -1.66 to 5.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 22 Day 1
|
-2.93 Units on a scale
Interval -6.79 to 0.94
|
-4.63 Units on a scale
Interval -9.0 to -0.26
|
-2.36 Units on a scale
Interval -5.68 to 0.96
|
-5.50 Units on a scale
Interval -8.87 to -2.12
|
—
|
—
|
—
|
-2.39 Units on a scale
Interval -6.73 to 1.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Cycle 26 Day 1
|
-5.50 Units on a scale
Interval -10.67 to -0.33
|
—
|
-3.03 Units on a scale
Interval -10.01 to 3.95
|
-4.30 Units on a scale
Interval -11.31 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
End of treatment
|
-4.77 Units on a scale
Interval -9.23 to -0.32
|
-0.73 Units on a scale
Interval -5.61 to 4.15
|
-2.55 Units on a scale
Interval -5.28 to 0.18
|
-3.22 Units on a scale
Interval -5.49 to -0.95
|
0.74 Units on a scale
Interval -2.7 to 4.17
|
—
|
—
|
-2.08 Units on a scale
Interval -5.65 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
The Detection Test is a measure of psychomotor function and uses a well validated simple reaction time paradigm with playing card stimuli. In this test, the on-screen instructions ask: "Has the card turned over?". A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as the card flips over the participant must press "Yes". The participant is encouraged to work as quickly as they can and be as accurate as possible. The speed and accuracy of each response are recorded and mean of the log10 transformed reaction times for correct responses is calculated. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=24 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=50 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=46 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=38 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=29 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 3 Day 1
|
-0.01 Units on a scale
Interval -0.05 to 0.03
|
0.01 Units on a scale
Interval -0.03 to 0.05
|
0.01 Units on a scale
Interval -0.02 to 0.04
|
-0.01 Units on a scale
Interval -0.04 to 0.02
|
-0.01 Units on a scale
Interval -0.05 to 0.02
|
—
|
—
|
-0.01 Units on a scale
Interval -0.05 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 4 Day 1
|
0.03 Units on a scale
Interval -0.02 to 0.07
|
0.00 Units on a scale
Interval -0.04 to 0.04
|
-0.03 Units on a scale
Interval -0.06 to 0.0
|
-0.02 Units on a scale
Interval -0.05 to 0.01
|
-0.04 Units on a scale
Interval -0.07 to 0.0
|
—
|
—
|
-0.01 Units on a scale
Interval -0.06 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 2 Day 1
|
0.01 Units on a scale
Interval -0.04 to 0.05
|
0.04 Units on a scale
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 5 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 6 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 8 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 10 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 12 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 14 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 16 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 18 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 20 Day 1
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 22 Day 1
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Interval -0.12 to 0.08
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
Cycle 24 Day 1
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Interval -0.11 to 0.16
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Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)
End of treatment
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SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
The Identification Test is a measure of visual attention and uses a well validated choice reaction time paradigm with playing card stimuli. In this task, the playing cards are all red or black jokers. The on-screen instructions ask: "Is the card red?". A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as it flips over the participant must decide whether the card is red or not. If it is red the participant should press "Yes", and if it is not red the participant should press "No". The participant is encouraged to work as quickly and accurately as possible. The speed and accuracy of each response are recorded and mean of the log10 transformed reaction times for correct responses is calculated. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=24 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=50 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=46 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=38 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=29 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
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EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 3 Day 1
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 4 Day 1
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 5 Day 1
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 6 Day 1
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 8 Day 1
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Interval -0.06 to 0.0
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 10 Day 1
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Interval -0.06 to 0.0
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 12 Day 1
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 14 Day 1
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Interval -0.08 to 0.0
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 16 Day 1
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-0.09 Units on a scale
Interval -0.13 to -0.05
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Interval -0.04 to 0.04
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Interval -0.06 to 0.01
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Interval -0.13 to 0.0
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 18 Day 1
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-0.01 Units on a scale
Interval -0.06 to 0.05
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-0.05 Units on a scale
Interval -0.09 to 0.0
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-0.04 Units on a scale
Interval -0.08 to 0.0
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-0.07 Units on a scale
Interval -0.1 to -0.03
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-0.19 Units on a scale
Interval -0.29 to -0.09
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 20 Day 1
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-0.03 Units on a scale
Interval -0.1 to 0.04
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Interval -0.06 to 0.04
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Interval -0.08 to 0.02
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Interval -0.15 to -0.06
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 22 Day 1
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0.04 Units on a scale
Interval -0.03 to 0.11
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Interval -0.07 to 0.05
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Interval -0.11 to 0.0
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Interval -0.14 to -0.03
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
Cycle 24 Day 1
|
0.08 Units on a scale
Interval -0.01 to 0.18
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Interval -0.15 to 0.04
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Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)
End of treatment
|
-0.07 Units on a scale
Interval -0.13 to -0.02
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-0.03 Units on a scale
Interval -0.1 to 0.03
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Interval -0.06 to 0.02
|
-0.03 Units on a scale
Interval -0.06 to 0.01
|
-0.09 Units on a scale
Interval -0.14 to -0.05
|
—
|
—
|
-0.06 Units on a scale
Interval -0.11 to -0.01
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
The One Back Test is a measure of working memory and uses a well validated n back paradigm with playing cards. In this task, the on-screen instructions ask: "Is the previous card the same?". A playing card is presented in the center of the screen. The participant must decide whether the card is the same as the previous card. If it is the same the participant should press "Yes", and if not press "No". The participant is encouraged to work as quickly and accurately as possible. The speed and accuracy of each response are recorded, mean of the log10 transformed reaction times for correct responses is used to demonstrate speed of performance, and the arcsine transformation of the square root of the proportion of correct responses is used to demonstrate accuracy. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=24 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=50 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=46 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=38 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=29 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 18 Day 1
|
0.02 Units on a scale
Interval -0.06 to 0.09
|
0.01 Units on a scale
Interval -0.04 to 0.07
|
0.06 Units on a scale
Interval 0.02 to 0.11
|
-0.02 Units on a scale
Interval -0.06 to 0.03
|
-0.18 Units on a scale
Interval -0.3 to -0.06
|
—
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—
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0.05 Units on a scale
Interval -0.01 to 0.1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 20 Day 1
|
-0.06 Units on a scale
Interval -0.15 to 0.03
|
0.07 Units on a scale
Interval 0.0 to 0.13
|
0.02 Units on a scale
Interval -0.05 to 0.08
|
-0.01 Units on a scale
Interval -0.06 to 0.05
|
—
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—
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—
|
0.02 Units on a scale
Interval -0.04 to 0.09
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 22 Day 1
|
0.02 Units on a scale
Interval -0.07 to 0.11
|
0.05 Units on a scale
Interval -0.02 to 0.12
|
0.04 Units on a scale
Interval -0.03 to 0.11
|
-0.07 Units on a scale
Interval -0.14 to 0.0
|
—
|
—
|
—
|
0.03 Units on a scale
Interval -0.04 to 0.11
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 24 Day 1
|
0.09 Units on a scale
Interval -0.03 to 0.21
|
—
|
—
|
0.01 Units on a scale
Interval -0.11 to 0.13
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
End of treatment
|
-0.03 Units on a scale
Interval -0.1 to 0.05
|
0.03 Units on a scale
Interval -0.05 to 0.11
|
0.03 Units on a scale
Interval -0.02 to 0.07
|
0.01 Units on a scale
Interval -0.04 to 0.05
|
-0.03 Units on a scale
Interval -0.08 to 0.02
|
—
|
—
|
0.02 Units on a scale
Interval -0.05 to 0.08
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 2 Day 1
|
0.01 Units on a scale
Interval -0.02 to 0.05
|
0.02 Units on a scale
Interval -0.01 to 0.05
|
0.02 Units on a scale
Interval 0.0 to 0.05
|
0.01 Units on a scale
Interval -0.01 to 0.04
|
0.02 Units on a scale
Interval -0.01 to 0.05
|
—
|
—
|
0.01 Units on a scale
Interval -0.02 to 0.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 3 Day 1
|
0.06 Units on a scale
Interval 0.02 to 0.09
|
0.01 Units on a scale
Interval -0.02 to 0.05
|
0.01 Units on a scale
Interval -0.01 to 0.04
|
0.01 Units on a scale
Interval -0.02 to 0.03
|
-0.01 Units on a scale
Interval -0.04 to 0.02
|
—
|
—
|
-0.00 Units on a scale
Interval -0.04 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 4 Day 1
|
0.04 Units on a scale
Interval 0.01 to 0.08
|
0.03 Units on a scale
Interval 0.0 to 0.06
|
0.02 Units on a scale
Interval -0.01 to 0.04
|
-0.01 Units on a scale
Interval -0.04 to 0.01
|
-0.02 Units on a scale
Interval -0.05 to 0.01
|
—
|
—
|
-0.01 Units on a scale
Interval -0.05 to 0.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 5 Day 1
|
0.02 Units on a scale
Interval -0.01 to 0.06
|
0.03 Units on a scale
Interval 0.0 to 0.07
|
0.03 Units on a scale
Interval 0.0 to 0.05
|
-0.01 Units on a scale
Interval -0.04 to 0.02
|
-0.02 Units on a scale
Interval -0.05 to 0.01
|
—
|
—
|
0.02 Units on a scale
Interval -0.01 to 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 6 Day 1
|
0.03 Units on a scale
Interval -0.01 to 0.06
|
0.03 Units on a scale
Interval 0.0 to 0.07
|
0.03 Units on a scale
Interval 0.01 to 0.06
|
0.01 Units on a scale
Interval -0.02 to 0.04
|
-0.00 Units on a scale
Interval -0.03 to 0.03
|
—
|
—
|
0.01 Units on a scale
Interval -0.03 to 0.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 8 Day 1
|
0.03 Units on a scale
Interval -0.01 to 0.06
|
0.02 Units on a scale
Interval -0.02 to 0.06
|
0.03 Units on a scale
Interval 0.0 to 0.05
|
0.01 Units on a scale
Interval -0.02 to 0.03
|
-0.01 Units on a scale
Interval -0.04 to 0.02
|
—
|
—
|
0.01 Units on a scale
Interval -0.02 to 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 10 Day 1
|
0.07 Units on a scale
Interval 0.03 to 0.11
|
0.03 Units on a scale
Interval 0.0 to 0.07
|
0.03 Units on a scale
Interval 0.0 to 0.05
|
0.02 Units on a scale
Interval -0.01 to 0.05
|
-0.01 Units on a scale
Interval -0.05 to 0.02
|
—
|
—
|
0.01 Units on a scale
Interval -0.02 to 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 12 Day 1
|
0.05 Units on a scale
Interval 0.01 to 0.08
|
0.01 Units on a scale
Interval -0.03 to 0.05
|
0.02 Units on a scale
Interval -0.01 to 0.05
|
0.01 Units on a scale
Interval -0.02 to 0.04
|
-0.00 Units on a scale
Interval -0.04 to 0.03
|
—
|
—
|
0.03 Units on a scale
Interval -0.01 to 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 14 Day 1
|
0.00 Units on a scale
Interval -0.05 to 0.05
|
0.03 Units on a scale
Interval -0.01 to 0.07
|
0.03 Units on a scale
Interval -0.01 to 0.07
|
-0.00 Units on a scale
Interval -0.04 to 0.03
|
0.01 Units on a scale
Interval -0.04 to 0.06
|
—
|
—
|
0.02 Units on a scale
Interval -0.03 to 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)
Cycle 16 Day 1
|
0.03 Units on a scale
Interval -0.03 to 0.08
|
0.05 Units on a scale
Interval -0.01 to 0.1
|
0.05 Units on a scale
Interval 0.0 to 0.09
|
-0.02 Units on a scale
Interval -0.05 to 0.02
|
-0.01 Units on a scale
Interval -0.1 to 0.08
|
—
|
—
|
0.03 Units on a scale
Interval -0.03 to 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
The International Shopping List task is a measure of verbal learning and uses a well validated list learning paradigm administered using a computer. High frequencies, high imagery, concrete nouns (items from a shopping list) were read to the participant at the rate of one word every 2 seconds. Once all 12 words had been read, the participant was asked to recall as many of the words as quickly as possible. The words recalled by the participant were marked on the computer screen. When the participant could recall no more words, the same list was read again. The words recalled by the participant were recorded. This was then repeated a third time. Total number of correct responses on 3 consecutive trials at a single assessment was recorded. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=24 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=50 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=46 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=38 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=29 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 2 Day 1
|
-0.02 Units on a scale
Interval -1.89 to 1.84
|
-1.13 Units on a scale
Interval -2.9 to 0.64
|
0.25 Units on a scale
Interval -1.01 to 1.52
|
-0.45 Units on a scale
Interval -1.76 to 0.86
|
0.96 Units on a scale
Interval -0.5 to 2.43
|
—
|
—
|
0.16 Units on a scale
Interval -1.51 to 1.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 3 Day 1
|
0.19 Units on a scale
Interval -1.66 to 2.03
|
-0.81 Units on a scale
Interval -2.58 to 0.96
|
0.14 Units on a scale
Interval -1.15 to 1.43
|
-1.04 Units on a scale
Interval -2.36 to 0.29
|
-0.08 Units on a scale
Interval -1.59 to 1.44
|
—
|
—
|
-0.56 Units on a scale
Interval -2.21 to 1.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 4 Day 1
|
0.58 Units on a scale
Interval -1.26 to 2.42
|
0.26 Units on a scale
Interval -1.54 to 2.05
|
0.28 Units on a scale
Interval -1.05 to 1.61
|
0.24 Units on a scale
Interval -1.12 to 1.6
|
1.30 Units on a scale
Interval -0.26 to 2.86
|
—
|
—
|
-0.87 Units on a scale
Interval -2.59 to 0.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 5 Day 1
|
1.30 Units on a scale
Interval -0.51 to 3.12
|
-0.66 Units on a scale
Interval -2.53 to 1.21
|
0.59 Units on a scale
Interval -0.77 to 1.95
|
-0.94 Units on a scale
Interval -2.33 to 0.45
|
1.23 Units on a scale
Interval -0.36 to 2.82
|
—
|
—
|
0.74 Units on a scale
Interval -0.97 to 2.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 6 Day 1
|
0.18 Units on a scale
Interval -1.64 to 1.99
|
0.81 Units on a scale
Interval -1.06 to 2.68
|
0.50 Units on a scale
Interval -0.87 to 1.87
|
0.08 Units on a scale
Interval -1.31 to 1.47
|
0.82 Units on a scale
Interval -0.83 to 2.46
|
—
|
—
|
-0.51 Units on a scale
Interval -2.31 to 1.29
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 8 Day 1
|
0.84 Units on a scale
Interval -1.0 to 2.68
|
0.60 Units on a scale
Interval -1.3 to 2.5
|
1.69 Units on a scale
Interval 0.29 to 3.08
|
0.15 Units on a scale
Interval -1.27 to 1.57
|
0.44 Units on a scale
Interval -1.23 to 2.11
|
—
|
—
|
1.70 Units on a scale
Interval -0.11 to 3.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 10 Day 1
|
0.26 Units on a scale
Interval -1.68 to 2.21
|
2.59 Units on a scale
Interval 0.65 to 4.52
|
0.86 Units on a scale
Interval -0.56 to 2.27
|
0.13 Units on a scale
Interval -1.46 to 1.72
|
2.29 Units on a scale
Interval 0.53 to 4.05
|
—
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—
|
0.97 Units on a scale
Interval -0.99 to 2.93
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 12 Day 1
|
2.87 Units on a scale
Interval 0.86 to 4.88
|
0.02 Units on a scale
Interval -2.06 to 2.1
|
0.11 Units on a scale
Interval -1.52 to 1.73
|
0.69 Units on a scale
Interval -0.98 to 2.35
|
1.74 Units on a scale
Interval -0.25 to 3.72
|
—
|
—
|
3.10 Units on a scale
Interval 1.06 to 5.14
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 14 Day 1
|
1.91 Units on a scale
Interval -0.71 to 4.53
|
1.46 Units on a scale
Interval -0.85 to 3.78
|
2.27 Units on a scale
Interval 0.36 to 4.17
|
0.94 Units on a scale
Interval -0.86 to 2.73
|
-4.43 Units on a scale
Interval -7.11 to -1.75
|
—
|
—
|
2.67 Units on a scale
Interval 0.09 to 5.25
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 16 Day 1
|
4.52 Units on a scale
Interval 1.58 to 7.46
|
0.87 Units on a scale
Interval -2.06 to 3.79
|
1.36 Units on a scale
Interval -1.11 to 3.84
|
1.04 Units on a scale
Interval -0.99 to 3.07
|
3.46 Units on a scale
Interval -1.26 to 8.18
|
—
|
—
|
1.97 Units on a scale
Interval -0.93 to 4.87
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 18 Day 1
|
4.77 Units on a scale
Interval 0.82 to 8.73
|
0.66 Units on a scale
Interval -2.5 to 3.81
|
-0.27 Units on a scale
Interval -2.89 to 2.36
|
-0.52 Units on a scale
Interval -2.77 to 1.73
|
-0.35 Units on a scale
Interval -6.9 to 6.21
|
—
|
—
|
3.13 Units on a scale
Interval 0.0 to 6.27
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 20 Day 1
|
-2.72 Units on a scale
Interval -7.47 to 2.03
|
-1.44 Units on a scale
Interval -4.91 to 2.03
|
0.56 Units on a scale
Interval -2.81 to 3.92
|
1.20 Units on a scale
Interval -1.84 to 4.24
|
—
|
—
|
—
|
0.56 Units on a scale
Interval -2.89 to 4.01
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 22 Day 1
|
-5.72 Units on a scale
Interval -10.47 to -0.97
|
-0.28 Units on a scale
Interval -4.22 to 3.66
|
2.17 Units on a scale
Interval -1.68 to 6.01
|
-0.36 Units on a scale
Interval -4.21 to 3.48
|
—
|
—
|
—
|
3.99 Units on a scale
Interval 0.07 to 7.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
Cycle 24 Day 1
|
-8.49 Units on a scale
Interval -15.06 to -1.92
|
—
|
—
|
-3.35 Units on a scale
Interval -9.86 to 3.16
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)
End of treatment
|
1.02 Units on a scale
Interval -2.99 to 5.04
|
-1.62 Units on a scale
Interval -5.95 to 2.71
|
0.80 Units on a scale
Interval -1.8 to 3.4
|
-0.27 Units on a scale
Interval -2.47 to 1.92
|
2.37 Units on a scale
Interval -0.54 to 5.27
|
—
|
—
|
-0.60 Units on a scale
Interval -4.09 to 2.89
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)Population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
This test was performed in the same way as the International Shopping List Test, with the exception that, the delayed recall condition required the participant to recall the words from the list 15 30 minutes later without having the list read again. During the recognition condition, the qualified personnel read a shopping list item that may or may not have been on the original list and the participant had to respond either affirmatively (if the item was on the original list) or negatively (if it was not). Total number of correct responses made in remembering the word list after a delay was recorded. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=24 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=26 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=50 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=46 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=38 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=29 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 14 Day 1
|
0.38 Units on a scale
Interval -0.99 to 1.75
|
0.06 Units on a scale
Interval -1.15 to 1.27
|
1.06 Units on a scale
Interval 0.06 to 2.06
|
0.11 Units on a scale
Interval -0.85 to 1.07
|
-1.80 Units on a scale
Interval -3.31 to -0.3
|
—
|
—
|
0.35 Units on a scale
Interval -1.0 to 1.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 2 Day 1
|
0.10 Units on a scale
Interval -0.85 to 1.06
|
-0.84 Units on a scale
Interval -1.76 to 0.08
|
-0.12 Units on a scale
Interval -0.77 to 0.53
|
-0.59 Units on a scale
Interval -1.28 to 0.09
|
-0.22 Units on a scale
Interval -0.96 to 0.53
|
—
|
—
|
-0.25 Units on a scale
Interval -1.11 to 0.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 3 Day 1
|
-0.33 Units on a scale
Interval -1.28 to 0.62
|
-1.32 Units on a scale
Interval -2.24 to -0.4
|
-0.14 Units on a scale
Interval -0.81 to 0.52
|
-0.77 Units on a scale
Interval -1.46 to -0.07
|
-0.87 Units on a scale
Interval -1.64 to -0.1
|
—
|
—
|
-0.30 Units on a scale
Interval -1.15 to 0.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 4 Day 1
|
-0.44 Units on a scale
Interval -1.38 to 0.5
|
-0.91 Units on a scale
Interval -1.86 to 0.03
|
0.03 Units on a scale
Interval -0.66 to 0.72
|
-0.25 Units on a scale
Interval -0.97 to 0.47
|
-0.02 Units on a scale
Interval -0.82 to 0.78
|
—
|
—
|
-1.06 Units on a scale
Interval -1.95 to -0.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 5 Day 1
|
-0.35 Units on a scale
Interval -1.29 to 0.59
|
-0.57 Units on a scale
Interval -1.54 to 0.4
|
0.02 Units on a scale
Interval -0.69 to 0.73
|
-0.46 Units on a scale
Interval -1.2 to 0.27
|
0.09 Units on a scale
Interval -0.74 to 0.92
|
—
|
—
|
0.17 Units on a scale
Interval -0.72 to 1.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 6 Day 1
|
0.48 Units on a scale
Interval -0.46 to 1.42
|
-0.38 Units on a scale
Interval -1.35 to 0.59
|
0.12 Units on a scale
Interval -0.59 to 0.84
|
-0.22 Units on a scale
Interval -0.95 to 0.52
|
0.30 Units on a scale
Interval -0.55 to 1.15
|
—
|
—
|
-0.28 Units on a scale
Interval -1.21 to 0.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 8 Day 1
|
0.56 Units on a scale
Interval -0.38 to 1.5
|
-0.24 Units on a scale
Interval -1.23 to 0.75
|
0.02 Units on a scale
Interval -0.7 to 0.74
|
-0.49 Units on a scale
Interval -1.24 to 0.25
|
-1.08 Units on a scale
Interval -1.94 to -0.22
|
—
|
—
|
-0.16 Units on a scale
Interval -1.1 to 0.77
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 10 Day 1
|
0.29 Units on a scale
Interval -0.74 to 1.31
|
0.80 Units on a scale
Interval -0.22 to 1.82
|
0.54 Units on a scale
Interval -0.2 to 1.28
|
0.23 Units on a scale
Interval -0.61 to 1.08
|
0.25 Units on a scale
Interval -0.67 to 1.16
|
—
|
—
|
-0.00 Units on a scale
Interval -1.02 to 1.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 12 Day 1
|
0.90 Units on a scale
Interval -0.15 to 1.95
|
0.13 Units on a scale
Interval -0.95 to 1.21
|
0.22 Units on a scale
Interval -0.63 to 1.07
|
0.19 Units on a scale
Interval -0.7 to 1.07
|
0.60 Units on a scale
Interval -0.43 to 1.64
|
—
|
—
|
0.42 Units on a scale
Interval -0.64 to 1.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 16 Day 1
|
0.89 Units on a scale
Interval -0.66 to 2.43
|
0.52 Units on a scale
Interval -1.02 to 2.05
|
0.68 Units on a scale
Interval -0.62 to 1.98
|
-0.12 Units on a scale
Interval -1.22 to 0.98
|
0.40 Units on a scale
Interval -2.09 to 2.88
|
—
|
—
|
-0.22 Units on a scale
Interval -1.75 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 18 Day 1
|
1.06 Units on a scale
Interval -1.02 to 3.14
|
0.68 Units on a scale
Interval -0.98 to 2.34
|
0.38 Units on a scale
Interval -1.0 to 1.76
|
-0.24 Units on a scale
Interval -1.54 to 1.07
|
-0.39 Units on a scale
Interval -3.85 to 3.07
|
—
|
—
|
-0.33 Units on a scale
Interval -1.97 to 1.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 20 Day 1
|
-1.22 Units on a scale
Interval -3.73 to 1.28
|
0.16 Units on a scale
Interval -1.67 to 1.98
|
-0.24 Units on a scale
Interval -2.01 to 1.53
|
-0.18 Units on a scale
Interval -1.78 to 1.43
|
—
|
—
|
—
|
-0.70 Units on a scale
Interval -2.52 to 1.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 22 Day 1
|
-3.22 Units on a scale
Interval -5.73 to -0.72
|
0.68 Units on a scale
Interval -1.4 to 2.76
|
0.80 Units on a scale
Interval -1.23 to 2.83
|
-0.64 Units on a scale
Interval -2.67 to 1.39
|
—
|
—
|
—
|
0.37 Units on a scale
Interval -1.7 to 2.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
Cycle 24 Day 1
|
-2.43 Units on a scale
Interval -5.89 to 1.04
|
—
|
—
|
-0.80 Units on a scale
Interval -4.25 to 2.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)
End of treatment
|
-0.87 Units on a scale
Interval -2.99 to 1.24
|
-2.31 Units on a scale
Interval -4.58 to -0.04
|
0.52 Units on a scale
Interval -0.84 to 1.89
|
-0.85 Units on a scale
Interval -2.06 to 0.35
|
-0.19 Units on a scale
Interval -1.71 to 1.34
|
—
|
—
|
0.11 Units on a scale
Interval -1.72 to 1.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to end of treatment maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.
PR Interval was determined by ECG measurement. PR interval had following categories: change from baseline\>=25 percent, 40 to \<60 milliseconds (msec), 60 to \<80 msec and \>=80 msec. Baseline was defined as the average of the triplicate measurements prior to the first dose of study drug.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=29 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=59 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=64 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
Change from baseline: >25%
|
4 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
—
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
Absolute value: 40-<60 msec
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
Absolute value: 60-<80 msec
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
Absolute value: >=80 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dose of study treatment to end of treatment maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)Population: ITT analysis set was used for overall response assessment and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with central nervous system (CNS) metastases in the ITT analysis set were used for intracranial response assessment. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 milliliter (mm) on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 percent (%) or more decrease in sum of lesion dimensions (SLD) of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.
Outcome measures
| Measure |
10 mg QD (Phase 1)
n=30 Participants
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
50 mg QD (Phase 1)
n=27 Participants
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=60 Participants
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=65 Participants
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
200 mg QD (Phase 1)
n=46 Participants
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=32 Participants
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=47 Participants
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall and Intracranial Objective Response (Phase 2 and DDI Sub-study)
Objective response
|
90.0 Percentage of participants
Interval 73.5 to 97.9
|
77.8 Percentage of participants
Interval 57.7 to 91.4
|
56.7 Percentage of participants
Interval 43.2 to 69.4
|
40.0 Percentage of participants
Interval 28.0 to 52.9
|
37.0 Percentage of participants
Interval 23.2 to 52.5
|
40.6 Percentage of participants
Interval 23.7 to 59.4
|
—
|
38.3 Percentage of participants
Interval 24.5 to 53.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Overall and Intracranial Objective Response (Phase 2 and DDI Sub-study)
Intracranial objective response
|
75.0 Percentage of participants
Interval 34.9 to 96.8
|
58.8 Percentage of participants
Interval 32.9 to 81.6
|
66.7 Percentage of participants
Interval 48.2 to 82.0
|
53.3 Percentage of participants
Interval 37.9 to 68.3
|
43.2 Percentage of participants
Interval 27.1 to 60.5
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
—
|
56.0 Percentage of participants
Interval 34.9 to 75.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
10 mg QD (Phase 1)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
25 mg QD (Phase 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
50 mg QD (Phase 1)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
75 mg QD (Phase 1)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 6 deaths
100 mg QD (Phase 1)
Serious events: 10 serious events
Other events: 17 other events
Deaths: 9 deaths
150 mg QD (Phase 1)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
200 mg QD (Phase 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
35 mg BID (Phase 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
75 mg BID (Phase 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
100 mg BID (Phase 1)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Japan Lead-In Cohort (LIC)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
EXP-1 (Phase 2)
Serious events: 15 serious events
Other events: 30 other events
Deaths: 8 deaths
EXP-2 (Phase 2)
Serious events: 11 serious events
Other events: 27 other events
Deaths: 13 deaths
EXP-3 (Phase 2)
Serious events: 34 serious events
Other events: 59 other events
Deaths: 25 deaths
EXP-4 (Phase 2)
Serious events: 31 serious events
Other events: 65 other events
Deaths: 46 deaths
EXP-5 (Phase 2)
Serious events: 23 serious events
Other events: 45 other events
Deaths: 37 deaths
EXP-6 (Phase 2)
Serious events: 21 serious events
Other events: 47 other events
Deaths: 22 deaths
DDI Substudy
Serious events: 13 serious events
Other events: 32 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
10 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
25 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
50 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=12 participants at risk
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=17 participants at risk
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
150 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
200 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 participants at risk
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 participants at risk
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 participants at risk
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
Japan Lead-In Cohort (LIC)
n=3 participants at risk
Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
|
EXP-1 (Phase 2)
n=30 participants at risk
Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=46 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 participants at risk
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Substudy
n=32 participants at risk
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/64 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/64 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urethritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/64 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Assisted suicide
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary tumour thrombotic microangiopathy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Brainstem compression
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Schizophreniform disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
10 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
25 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
50 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg QD (Phase 1)
n=12 participants at risk
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg QD (Phase 1)
n=17 participants at risk
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
150 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
|
200 mg QD (Phase 1)
n=3 participants at risk
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
35 mg BID (Phase 1)
n=3 participants at risk
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
75 mg BID (Phase 1)
n=3 participants at risk
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
100 mg BID (Phase 1)
n=4 participants at risk
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
Japan Lead-In Cohort (LIC)
n=3 participants at risk
Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
|
EXP-1 (Phase 2)
n=30 participants at risk
Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-2 (Phase 2)
n=27 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-3 (Phase 2)
n=60 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-4 (Phase 2)
n=65 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-5 (Phase 2)
n=46 participants at risk
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
EXP-6 (Phase 2)
n=47 participants at risk
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
|
DDI Substudy
n=32 participants at risk
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.2%
7/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.7%
18/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.2%
7/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.9%
7/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
8/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Ventricular dysfunction
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Asthenopia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Astigmatism
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Presbyopia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.9%
7/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
9/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
29.6%
8/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.3%
11/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.6%
9/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
8/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.7%
11/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
12/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.8%
22/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.6%
9/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.1%
9/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.9%
7/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.0%
9/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.7%
18/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
10/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.1%
9/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Swollen tongue
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.3%
7/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
10/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.8%
9/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
8/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
12/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
8/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
8/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Catheter site extravasation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
5/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
29.4%
5/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
9/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.5%
14/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.2%
7/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.3%
10/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
5/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.8%
10/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
43.3%
13/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
55.6%
15/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
55.0%
33/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
38.5%
25/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
34.8%
16/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
53.2%
25/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
43.8%
14/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Performance status decreased
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
10/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
12/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.4%
10/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.9%
7/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Swelling
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Swelling face
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Candida infection
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
5/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.4%
10/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.7%
11/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.8%
9/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
12/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
8/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
7/7 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Amino acid level increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Amylase increased
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
29.4%
5/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
5/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.3%
10/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.7%
8/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
13/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.6%
9/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
6/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.7%
11/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
48.1%
13/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
31.7%
19/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
29.2%
19/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
34.8%
16/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.4%
19/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
53.1%
17/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Candida test positive
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Ejection fraction decreased
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.6%
9/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Glucose urine present
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lipase increased
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
29.4%
5/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.4%
10/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.2%
7/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.1%
9/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.7%
16/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
38.5%
25/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.1%
12/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.4%
11/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.1%
9/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.3%
7/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
70.6%
12/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
53.3%
16/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
51.9%
14/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
55.0%
33/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.5%
38/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.7%
27/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
53.2%
25/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
46.9%
15/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.2%
7/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
76.7%
23/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
59.3%
16/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
61.7%
37/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
69.2%
45/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
69.6%
32/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
53.2%
25/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
71.9%
23/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
35.3%
6/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
10/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.9%
7/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.7%
16/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.7%
18/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
32.6%
15/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
38.3%
18/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.8%
6/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
35.3%
6/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.3%
7/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
8/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.1%
15/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.8%
6/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
5/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.8%
9/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.9%
7/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
37.0%
10/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.3%
11/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
8/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.0%
8/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Aphasia
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Bradykinesia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.7%
8/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
12/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.4%
8/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.7%
13/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.8%
6/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Formication
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
6/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
29.6%
8/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.3%
14/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
12/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.3%
13/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
6/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
12/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
19.1%
9/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.3%
7/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
5/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
8/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.9%
11/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
5/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
13/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.3%
8/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.2%
7/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.9%
7/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
8/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.7%
7/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peroneal nerve palsy
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Sleep deficit
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Slow speech
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.6%
3/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Affect lability
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.8%
7/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
10/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.0%
6/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Reading disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Micturition urgency
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
12/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
9/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.3%
14/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
13/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.7%
10/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.3%
10/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.9%
7/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.5%
4/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.7%
8/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
6/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.7%
22/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.7%
18/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.9%
11/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.2%
17/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
31.2%
10/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.9%
5/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.2%
6/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.8%
6/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
5/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
66.7%
2/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.8%
2/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.7%
5/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.5%
4/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.7%
8/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.5%
5/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.8%
9/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Social circumstances
Menopause
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/50 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.9%
1/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
23.3%
7/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.8%
4/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.9%
11/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.6%
5/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Shock
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
4/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.7%
4/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.6%
3/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.5%
3/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
8/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mania
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
5/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.0%
3/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
4/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Ulcer
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.2%
1/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
3/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
13.3%
4/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
2/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.4%
3/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
2/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.3%
2/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
3/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.3%
1/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.4%
2/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.7%
1/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.5%
1/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
1/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/17 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.7%
2/30 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.7%
1/27 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/60 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/65 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/46 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/47 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • From first dose of study treatment to end of treatment (maximum of 96.58 months of treatment exposure for Phase 1, maximum of 89.65 months of treatment exposure for Phase 2 and maximum of 68.69 months of treatment exposure for DDI participants)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER